Parexel Blog

Parexel Blog

  • Rare Disease and Orphan Drug Designations - What You Need to Know

    Rare Disease and Orphan Drug Designations - What You Need to Know

    Collectively, rare diseases affect over 30 million Americans.  The Orphan Drug Act (ODA), which provides the statutory basis for FDA to designate a drug or biologic agent as a therapy for a...

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  • Critical Differences Between a Form FDA 483 and Warning Letters

    Critical Differences Between a Form FDA 483 and Warning Letters

    There are many publications and services that analyze the observations contained in Form FDA 483 documents issued to manufacturers at the close of an inspection by the U.S. Food and Drug...

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  • Does FDA Consistently Assess Product Quality Risk and Control in Applications?

    Does FDA Consistently Assess Product Quality Risk and Control in Applications?

    Early in 2018, the Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) published a “white paper” which contained recommendations that drug companies could consider...

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  • Reimagining The Global Value Dossier - Part 6

    Reimagining The Global Value Dossier - Part 6

    A clear value strategy is key to the success of any product attempting to enter the healthcare market; defining the right strategy should lead to the perfect positioning for your product and...

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  • Will FDA Withdraw an Approved Application Over Product Quality Problems?

    Will FDA Withdraw an Approved Application Over Product Quality Problems?

    There have been some recent headlines where the acting FDA Commissioner and other senior agency officials have stated that the FDA will consider the use of its full authorities to take...

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  • Don’t Shortchange Your Due Diligence When It Involves Applications – FDA Won’t

    Don’t Shortchange Your Due Diligence When It Involves Applications – FDA Won’t

    In a recent blog post, I wrote about how manufacturers can overcome data integrity problems that potentially imperil an application’s approval and commercializing a product. Sometimes...

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  • New PIC/S recommendation for evaluating PQS effectiveness in relation to risk-based change management

    New PIC/S recommendation for evaluating PQS effectiveness in relation to risk-based change management

    On November 28, 2019 the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a draft Recommendation for Participating Authorities, providing practical guidance for GMP...

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  • Commercial and Regulatory Strategy Considerations for Biotech

    Commercial and Regulatory Strategy Considerations for Biotech

    Many critical and innovative new therapies today, including those for rare and untreated diseases, are in the biotech pipeline. In fact, today biotech represents more than 80 percent of the...

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  • How to align your market access activities with your product value strategy

    How to align your market access activities with your product value strategy

    The value strategy (also termed value story) for your product should act as the cornerstone for all market access activities.  The value strategy drives your market access planning, which...

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  • A Long and Winding Road for Transdermal Products – FDA Has It Covered

    A Long and Winding Road for Transdermal Products – FDA Has It Covered

    On November 22, 2019 the Food and Drug Administration (FDA) published a Level 1 draft guidance titled Transdermal and Topical Delivery Systems - Product Development and Quality...

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  • Demystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring

    Demystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring

    What is KASA and why does FDA need it? Due to issues stemming from the large volume of generic drug applications submitted to the agency and the fact that some of the submissions are have...

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  • Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications

    Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications

    FDA released its Guidance for Industry (GFI) regarding Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers on October 22, 2019. ...

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  • Biosimilars in China

    Biosimilars in China

    In February 2019, National Drug Regulators in China approved the country’s first ever biosimilar product referencing Rituxan, a monoclonal antibody[1].  This biosimilar product, HLX01...

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  • Rescuing Product Approvals from Data Integrity Issues

    Rescuing Product Approvals from Data Integrity Issues

    The pharmaceutical industry is inundated with a plethora of communications about data integrity.  Most of those are focused on the downside – operational snags, negative inspection findings,...

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  • Reimagining the Global Value Dossier - Part 4

    Reimagining the Global Value Dossier - Part 4

    Health Technology Assessment (HTA) agencies are increasingly demanding the inclusion of patient-relevant data in submission dossiers. It is evident that there is an effort to ensure...

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  • Commercializing Gene and Cellular Therapy

    Commercializing Gene and Cellular Therapy

    Gene and cellular therapy manufacturing requires strict control in current Good Manufacturing Practice (cGMP) facilities.  Designing a facility or finding a contract manufacturer to meet the...

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  • Impact of MDR, Article 117 medicinal products with an integral medical device

    Impact of MDR, Article 117 medicinal products with an integral medical device

    The medical devices regulation (MDR) and in-vitro diagnostics regulation (IVDR) replace the three current Directives (93/42/EEC, 98/79/EC and 90/385/EEC) for medical devices. The Regulations...

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  • Critical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine

    Critical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine

    If you work in the pharmaceutical industry or follow the industry news, you’ve likely heard the phrases “Park doctrine” or “responsible corporate officer (RCO) doctrine” mentioned when the...

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  • Capturing the patient voice in market access communications

    Capturing the patient voice in market access communications

    Patients have unique perspectives on their conditions that, when incorporated into value communications, can provide an authenticity and salience which would otherwise be lacking. Who knows...

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  • Podcast: Driving Drug Development Innovation Through Patient Centricity

    Podcast: Driving Drug Development Innovation Through Patient Centricity

    This PharmaVoice podcast explores patient-centric trials as a key innovation in drug development.

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